FDAOctober 25, 2016device

Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.

What to do

FDA enforcement status: Terminated

Brands named

toshiba american medical systemstoshibatoshiba american

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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